AI-Driven Early Detection of Skin Cancer (Skin Cancer)

This study evaluates the feasibility and accuracy of an AI-powered mobile platform (NuvanaDx) for early detection of skin cancer, including melanoma, using smartphone-based imaging. The platform is designed to improve access to early diagnosis, reduce waiting times, and support triage into appropriate care pathways.

Study Overview

• Status: Recruiting
• Conditions: Skin Cancer Melanoma
• Intervention / Treatment: Diagnostic test: Smartphone-based AI skin lesion analysis (NuvanaDx platform).

Detailed Description

The study will collect retrospective and prospective anonymized skin lesion images and metadata to validate the AI algorithm against dermatology-confirmed diagnoses. The aim is to determine sensitivity, specificity, and predictive value of the AI tool across diverse populations and skin tones. The study will also assess user experience, accessibility, and integration into clinical care pathways.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sushma Saxena, Director, Nuvana Healthcare Ltd; Phone Number: +44 7481986525; Email: sushma.saxena@nuvana.co.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Nuvana Healthcare Ltd
    • Contact: Sushma Saxena, B.Tech, Msci; Phone Number: +44 7481986525; Email: sushma.saxena@nuvana.co.uk
    • Principal Investigator: Aryan Chaudhary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study Population Description: Individuals undergoing dermatology evaluation in UK clinics, supplemented by retrospective anonymized image datasets.

Description

Inclusion Criteria:

Adults (≥18 years) presenting with skin lesions suspicious for malignancy.

Ability to provide informed consent.

Exclusion Criteria:

Inability to provide informed consent.

Poor-quality images unsuitable for AI analysis.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with suspicious skin lesions undergoing AI-based image analysis and dermatologist confi	Diagnostic test: Smartphone-based AI skin lesion analysis (NuvanaDx platform).; Smartphone-based AI skin lesion analysis (NuvanaDx platform).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of AI tool compared with dermatologist-confirmed diagnosis	Diagnostic Accuracy of AI tool compared with dermatologist-confirmed diagnosis Time Frame: Up to 12 months Measure: Sensitivity, specificity, and predictive values	Time Frame: Up to 12 months

Collaborators and Investigators

• Sponsor: Nuvana Healthcare LTD
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Study Chair: Aryan Chaudhary,, Scientific Advisor / Co-Founder, Nuvana Healthcare

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 20, 2025
• First Submitted That Met QC Criteria: August 20, 2025
• First Posted (Estimated): August 27, 2025

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Skin Cancer; Melanoma; Artificial Intelligence; Digital Health; Dermatology; Early Detection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin and Connective Tissue Diseases; Melanoma; Skin Neoplasms
• Other Study ID Numbers: 70148; 359904 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual Participant Data (IPD) that underlie the results of this study will be shared after de-identification. This will include anonymized image datasets of skin lesions (with corresponding dermatology-confirmed diagnoses), demographic variables (age, sex), and relevant clinical outcomes. No personally identifiable information (PII) will be shared. Data will be made available for the purpose of secondary analysis, validation studies, and meta-analyses in the field of dermatology, oncology, and digital health.
• IPD Sharing Time Frame: De-identified IPD and supporting information will be available beginning 6 months after study completion (anticipated June 2027). Data will remain available for at least 5 years (until December 2032), after which access will be reviewed and may be extended based on scientific demand.
• IPD Sharing Access Criteria: Access will be granted to qualified researchers affiliated with academic institutions, non-profit organizations, or healthcare systems, upon submission of a research proposal that aligns with the study's objectives. Proposals will be reviewed by Nuvana Healthcare's Scientific Advisory Board. Data will be shared under a data use agreement (DUA) to ensure confidentiality and compliance with ethical standards. Access will be provided through a secure, password-protected platform, with no download of raw datasets permitted unless explicitly approved.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No